Archive for February, 2023

FDA Provides Update on Proposed Human Foods Program and Office of Regulatory Affairs Restructuring

Today, the U.S. Food and Drug Administration announced that it has begun a national search for a new Deputy Commissioner for Human Foods and is providing…

FDA Takes Action to Restrict Unlawful Import of Xylazine

Today, the U.S. Food and Drug Administration announced that it has taken action to restrict the unlawful entry of xylazine active pharmaceutical ingredients and finished…

FDA Roundup: February 28, 2023

February 28, 2023

Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:  Today, the FDA is withdrawing the 2005…

FDA Outlines Steps to Strengthen Tobacco Program

Today, the U.S. Food and Drug Administration’s Center for Tobacco Products (CTP) outlined the steps it plans to take in response to an external evaluation…

FDA Roundup: February 24, 2023

February 24, 2023

Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:  Today, the FDA published the FDA Voices:…

FDA Files Civil Money Penalty Complaints Against Four E-Cigarette Product Manufacturers

Today, the U.S. Food and Drug Administration announced it has filed civil money penalty (CMP) complaints against four tobacco product manufacturers for manufacturing and selling…

FDA Provides Draft Labeling Recommendations for Plant-based Milk Alternatives to Inform Consumers

Today, the U.S. Food and Drug Administration announced draft recommendations for industry on the naming of plant-based foods that are marketed and sold as alternatives…

FDA Roundup: February 17, 2023

February 17, 2023

Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:  On Thursday, the FDA approved Lamzede (velmanase…

Use of Fast Healthcare Interoperability Resources (FHIR) in the Generation of Real World Evidence (RWE)

Regina Zopf, FDA, Bethesda, MD, USA Jeff Abolafia, Rho, Chapel Hill, NC, USA Bhargava Reddy, UCB, Raleigh, NC USA ABSTRACT There is a lot of…

La FDA lleva a cabo actividades adicionales para prevenir las sobredosis de drogas y reducir los fallecimientos

Abordar la crisis de sobredosis de drogas y el trastorno por consumo de sustancias (SUD, por sus siglas en inglés) es un tema de gran…